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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Scar Tissue (2060); Metal Related Pathology (4530)
Event Date 11/27/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: cat# us157854 m2a-magnum pf cup lot# 868680, cat# x180309 bi-metric/x por nc 9x125 lot# 416780,and cat# 139259 m2a magnum 42-50m lot# 330050. Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the patient underwent a left hip revision approximately 10 years post implantation due to altr. During the revision scar tissue and adhesions were noted. The head was exchanged without complications. The stem and cup remained implanted. No additional information.
 
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Brand NameM2A-MAGNUM MOD HD SZ 48MM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key13667031
MDR Text Key286577666
Report Number0001825034-2022-00437
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Model NumberN/A
Device Catalogue Number157448
Device Lot Number053360
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/04/2022 Patient Sequence Number: 1
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